Category Access to Medicine

WHO and MPP Announce Agreement with NIH for COVID-19 Health Technologies

[Medicines Patent Pool] WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalised a licensing agreement with the United States National Institutes of Health (NIH) for the development of several innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19. The licences, which are transparent, global and non-exclusive, will allow manufacturers from around the world to work with MPP and C-TAP to make these technologies accessible to people living in low- and middle-income countries and help put an end to the pandemic. The 11 COVID-19 technologies offered under two licences include the stabilised spike protein used in currently available COVID-19 vaccines, research tools for vaccine, therapeutic and diagnostic development as well as early-stage vaccine candidates and diagnostics.

19 Vaccines as Global Public Goods: Between Life and Profit

[Katiuska King Mantilla and César Carranza Barona] Abstract: In the context of a health emergency like the COVID-19 pandemic, the global availability of and access to vaccines are imperative. This research paper provides an analysis from the perspective of international political economy, of the financing of COVID-19 vaccines and of the market strategies adopted by some of the companies that developed them. It notes that the development of vaccines was supported by substantial public funding from countries that later received preferential access to those vaccines through advance purchases. Despite such public support, the vaccines were not deemed as public goods but remained under the control of their developers.

Patent Law and 3D Printing Applications in Response to COVID-19: Exceptions to Inventor Rights

[Muhammad Zaheer Abbas] Abstract: ... This paper examines the issue of patent rights being at odds with access to critical 3D printable health technologies during COVID-19 crisis. It undertakes an in-depth analysis of the right to repair and calls for a clearer recognition of the right to repair exemption at the global level. It also evaluates the private and non-commercial use exception and proposes the use of a reasonably broad form of this exception to make it practically significant. It also considers the experimental use exception and calls upon WTO Member States to provide legislative clarity that a defence of an experimental use extends to repairs.

An Examination of Selected Public Health Exceptions in Asian Patent Laws

[Kiyoshi Adachi] This study examines the variations within Asia of two exceptions to patent rights that are commonly justified under Article 30 of the World Trade Organization (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), namely the research and experimentation exception and the regulatory review (or “Bolar”) exception. Both these exceptions are important in the context of the 2001 Doha Declaration on the TRIPS Agreement and Public Health insofar as they are designed to provide flexibility to protect public health and support countries’ overall scientific and technological aspirations. The study examines, from a comparative perspective, examples of these respective exceptions in patent legislation in South, Southeast and East Asia, and identifies peculiarities in the variations among countries in these sub-regions.

What Is the Impact of Intellectual Property Rules on Access to Medicines? A Systematic Review

[Brigitte Tenni, Hazel V. J. Moir, Belinda Townsend, Burcu Kilic, Anne‑Maree Farrell, Tessa Keegel and Deborah Gleeson] Abstract: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains ‘flexibilities’ designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions.

Reverse Payment: A Comparative Study

[Garry Gabison and Zaakir Tameez] Abstract: This Article compares reverse payment settlements, also known as pay-for-delay deals, in the United States and Europe. These deals occur where a branded drug manufacturer sues, settles with, and pays a generic manufacturer to delay the entry of its generic. Unlike the United States, which has a decentralized drug purchasing system, European healthcare systems such as those in France and the United Kingdom wield monopsony buying power over drugs. We investigate whether regulator and monopsony power can neutralize these anticompetitive agreements.

Lessons From the Pandemic for LDCs: Implementing Intellectual Property Flexibilities

[Sangeeta Shashikant] The global crisis of COVID-19 has underscored the vital importance of utilizing, to the fullest extent, policy space in the area of intellectual property. Since the onset of the pandemic, many countries around the world have had to confront various challenges of access including to tools protected by intellectual property (IP). These include copyrighted materials as learning shifted to online platforms, and affordable health products and technologies to prevent and treat the infection. The pandemic has also accentuated the significance of local production as limited supplies of critical commodities are rapidly snapped up by developed countries. Since March 2020, the least developed countries (LDCs) have perhaps struggled the most with limited financial resources, facilities and technological capacity to contain the pandemic and deal with its socioeconomic impacts.

Statement on the Leaked Covid-19 TRIPS Waiver Proposal

[Sean Flynn] The proposal to reach an agreement on a TRIPS waiver is a bit of a misnomer since it largely affirms and adds new requirements to TRIPS rather than waive its provisions. The proposal fails to accept the requests of researchers and access to knowledge organizations that the waiver extend to all intellectual property for vaccines, treatments and devices needed to combat COVID.

The WTO TRIPS Waiver and Essential Security Rights in 2022

[Dr. Alexander Beyleveld] Almost two years have passed since the start of the COVID-19 pandemic, and we are still far from bringing the pandemic to an end. One of the main reasons for this is the fact that large vaccine inequities remain worldwide. In order to address this problem, a large subset of World Trade Organization (WTO) members are in favour of waiving certain obligations contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). Against this backdrop, this article contemplates the legal necessity of such a waiver given that Article 73 of the TRIPS Agreement contains essential security exceptions which may render the obligations in question inapplicable under the interpretation that the pandemic affects law and public order interests.

Can Negotiations at the World Health Organization Lead to a Just Framework for the Prevention, Preparedness and Response to Pandemics as Global Public Goods?

[Viviana Muñoz Tellez] This paper advances that WHO Member States, having agreed to the objectives of advancing equity and solidarity for future pandemic prevention, preparedness and response, now must operationalize these. The paper offers suggestions for the ongoing WHO processes of: 1) review of recommendations under examination by the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, 2) consideration of potential amendments to the International Health Regulations (IHR) 2005, and 3) elaboration of a draft text for an international instrument on pandemic preparedness and response.

Access To Medicines and Pharmaceutical Patents: Fulfilling The Promise of TRIPS Article 31bis

[Ezinne Miriam Igbokwe and Andrea Tosato] Abstract: ... The most contentious [TRIPS] issue has long been the impact of the TRIPS patents regime on access to medicines. Our Article contributes to this debate by illuminating an oft-overlooked facet of TRIPS: Article 31bis. Enacted following the Doha Declaration of 2001, this provision was designed to enable Members with inadequate manufacturing capabilities to import patented pharmaceuticals produced by generics manufacturers under an export compulsory license (ECL) issued by another Member. Initially welcomed with enthusiasm, ECLs have enjoyed minimal success. We propose an explanation for the current fallow state of Article 31bis and suggest approaches to fulfill its promise.